The Diabetes Prevention Trial of Type 1 Diabetes is the combination of two
studies envisioned to be the first in a series of studies designed to test
the potential to prevent or delay the onset of Type 1 diabetes mellitus
(DM). Individuals can be placed into one of four risk groups for type 1 DM
based upon the presence or absence of various immunological markers as well
as tests of insulin secretion. Individuals can be found to be at "High
Risk", "Intermediate Risk", "Modest Risk", or
"Low Risk". The purpose of dividing individuals into these four
predictive risk groups is that specific intervention strategies are best
applied to them because of their stage in natural history, while the
invasiveness of the therapeutic approaches to be tested needs to be
appropriately reconciled with the estimated risk of Type 1 DM in the
different risk groups. For more information about DPT-1, visit the Questions
& Answers section.

The intervention protocol for the
"Intermediate Risk" group was designed to determine whether
presentation of an islet cell autoantigen (i.e. orally ingested insulin) to
the immune system via the intestinal mucosa could induce disease relevant
immunological tolerance, thereby delaying the development of Type 1 DM. This
study, which is now completed, was designed to be a
randomized, placebo-controlled, double-blind, multicenter clinical trial.
You can find out the results of this trial in NIH's News Release.

The protocol for the "High
Risk" group was designed to determine whether parenteral insulin
therapy, consisting of periodic courses of continuous intravenous insulin,
with accompanying chronic subcutaneous insulin, will delay their expected
development of clinical Type 1 DM. This now completed trial was a
randomized, controlled, multicenter clinical trial. You can find out the
results of this trial in NIH's
News Release.